Fungal Infection Therapy with Low Level Laser

ABSTRACT

A portable, small-footprint laser device contains one or more housings in which a laser energy source and an optical arrangement are disposed. The housing produces a laser beam spot that may be rotated and scanned to apply laser energy to a target area. The laser device receives treatment parameters and uses them to program a treatment regimen in which activation and movement of the housings is automated. The laser device may be used to apply a treatment regimen to a patient&#39;s hands or feet that are infected by Onychomycosis. In the treatment regimen, certain wavelengths of laser energy are applied at a predetermined duration. The treatment may be repeated, and a topical anti-fungal medication may be applied to aid in the efficacy of the treatment.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit and is a non-provisional applicationof U.S. Provisional Pat. App. Ser. No. 61/314,957, filed Mar. 17, 2010,and this application is a continuation-in-part of U.S. patentapplication Ser. No. 11/409,408, filed Apr. 20, 2006, which is acontinuation-in-part of U.S. patent application Ser. No. 10/976,581,filed Oct. 29, 2004, which is a continuation-in-part of U.S. patentapplication Ser. No. 10/772,738, filed Feb. 4, 2004, now U.S. Pat. No.7,118,588, which claims the benefit of U.S. patent application Ser. No.09/932,907 filed Aug. 20, 2001, now U.S. Pat. 6,746,473, which claimsthe benefit of U.S. Provisional Application No. 60/273,282 filed Mar. 2,2001, all of which are incorporated herein by reference.

FIELD OF INVENTION

This invention relates generally to therapies with a laser device. Moreparticularly, this invention relates to methods and devices for treatinga fungal infection with low level laser energy.

BACKGROUND

Onychomycosis (“OM”) is a fungal infection of toenails or fingernails.The infection may encompass any component of the nail, including thenail bed, nail plate, or nail matrix. OM can become very unsightly andmay produce pain, discomfort, and disfigurement, all of which can leadto physical and occupational limitations. A disorder such as OM may havea detrimental effect on an individual's quality of life, affecting hispsychosocial and emotional well-being. The main subtypes of OM aredistal lateral subungual OM (“DLSO”), white superficial OM (“WSO”),proximal subungual OM (“PSO”), endonyx OM (“EO”), and candidal OM.Patients may have a combination of these subtypes. Total dystrophic OMrefers to the most advanced form of any subtype. The onset of fungalinfection is caused by three main classes of fungi: dermatophytes,yeasts, and nondermatophyte molds. The most common cause of OM worldwideis due to the infection of dermatophytes, including the generaEpidermophyton, Microsporum, and Trichophyton. There are two majorpathogens that account for a majority of OM cases, Trichophyton rubrumand Trichophyton mentagrophytes.

There are several treatment options for clinicians, including systemicor topical antifungal medications and natural remedies. However, therate of success remains low, the rate of recurrence remains high, andthe costs and risks involved may be steep for some patients. Forexample, the most effective accepted treatments are prescription oralpharmaceuticals that have significant negative side effects, such asskin rash and liver damage. An effective alternative to pharmacologicalsolutions is needed that is safe for the patient and prevents recurrenceof the infection.

Low level laser therapy (“LLLT”) is used in the treatment of a broadrange of conditions. LLLT improves wound healing, reduces edema, andrelieves pain of various etiologies, including successful application towound and surgical sites to reduce inflammation and pain. LLLT is alsoused in the treatment and repair of injured muscles and tendons. LLLTutilizes low level laser energy, wherein the treatment has a dose ratethat causes no immediate detectable temperature rise of the treatedtissue and no macroscopically visible changes in tissue structure.Consequently, the treated and surrounding tissue is not heated ordamaged, and the patient feels no sensation during treatment. Some LLLTapplications have effectively photodestroyed a targeted biologicalelement under suitable treatment conditions. For example, LLLT may beused in fat reduction to create a transition pore in fat cell walls,through which fat is released into the interstitial space.

There are a number of variables in laser therapy, including thewavelength of the laser beam, the area impinged by the laser beam, theshape of the beam spot when it impinges the area, the power of the lasersource, the intensity or fluence of the laser energy, the laser pulsewidth, and the treatment duration. These variables typically dependheavily on the tissue characteristics of the specific patient, and thesuccess of each therapy depends on the relationship and combination ofthese variables. For example, fat reduction may be facilitated with oneregimen utilizing a given power, wavelength, and treatment duration,whereas pain may be treated with a regimen utilizing a differentwavelength and treatment duration, and inflammation a third regimen.Specific devices may be used for each type of therapy.

Therefore, an object of this invention is to provide laser therapydevices and methods of using the devices to treat OM and other fungalinfections of the fingernails or toenails. A further object of theinvention is to incite photodestruction of fungal bacteria withoutadversely affecting surrounding healthy tissue. It is another object ofthis invention to destroy fungal bacteria using laser light in multipledifferent pulse widths. It is a particular object of this invention toprovide methods of using a compact, standalone laser device to providelow level laser therapy which can be used to treat OM and other fungalinfections. It is another particular object of this invention to providemethods of using a hand-held therapeutic laser device to provide lowlevel laser therapy which can be used to treat OM and other fungalinfections.

SUMMARY OF THE INVENTION

This invention is a method of treating OM using a laser device that cansimultaneously emit one or more wavelengths of laser light. The deviceenables laser light of one or more pulse widths, one or more beamshapes, and one or more spot sizes to be applied externally to theaffected area of a patient's body. The laser light may be continuous orpulsed. The device may include multiple laser sources. In the preferredembodiment, two semiconductor diode laser sources simultaneously providetwo separate laser beams, one laser beam producing red laser light andthe other producing violet laser light. Most preferably, the lasersources are contained in a portable, compact, free-standing laser deviceinto which the patient places the infected hand or foot.

The laser device is activated and laser energy is scanned across theinfected area of the patient's first hand or foot. The laser energysource may be nearly touching the skin or held at a distance of up toabout 10 inches, or further, from the nail surface. The laser energy maybe applied for a duration of about 10 minutes to about 30 minutes on thepatient's first hand or foot. The application may be repeated on anotherinfected appendage if desired. The entire treatment may be repeatedafter the first application. Following the second treatment, the patientmay apply a topical anti-fungal medication for 12 weeks to preventre-infection.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an electrical and electromagnetic schematic illustration ofthe preferred embodiment of the present invention.

FIG. 2 is a schematic view of the optical arrangement of the linear spotshape of the preferred embodiment.

FIG. 3 is a perspective view of a scanning head optical arrangement ofthe present invention.

FIG. 4 is a perspective view of the scanning head of FIG. 3, explodedalong axes a and b.

FIG. 4 a is a perspective view of the universal carriage shown in FIG. 3holding a prism instead of a rod lens.

FIG. 5 is a perspective view showing application of low-level laserradiation using a hand-held wand.

FIG. 6 is a perspective view of a portable, floor-supported laser devicefor use with the present invention.

FIG. 7 is a perspective view of a wall-mounted laser device for use withthe present invention.

FIG. 8 a is an exploded perspective view of a portable, compact,free-standing laser device for use with the present invention.

FIG. 8 b is a front perspective view of the scanner assembly of thelaser device of FIG. 8 a.

FIG. 9 is a front right perspective view of the laser device of FIG. 8a.

FIG. 10 is a right side view of the laser device of FIGS. 8 a and 9,showing the door open and a patient's foot inserted for treatment.

FIG. 11 is a perspective view showing application of low-level laserradiation using the laser device of FIG. 7 or 8 a-10.

DETAILED DESCRIPTION OF THE INVENTION

Referring to the drawings, there are illustrated a plurality of laserdevices that may be used to perform the inventive methods herein, whichare methods for treating OM infections of the skin or nails. FIG. 1shows, schematically, the preferred electrical and electromagneticarrangement of the laser device, in which a first laser energy source 11and a second laser energy source 12 are connected to a power source 14.The power source 14 preferably provides direct current, such as thatprovided by a battery, but may instead provide alternating current, suchas that provided by conventional mains power, that is then converted todirect current. Switches 15, 16 are connected to the laser energysources 11, 12 respectively and control the period of time the laserlight is generated. These laser energy sources can be energizedindependently or simultaneously which, throughout this specification,refers to acts occurring at generally the same time.

The laser energy sources 11, 12 may be any source suitable for LLLT,including Helium-Neon lasers having a 632 nm wavelength and either solidstate or tunable semiconductor laser diodes with a range of wavelengthsbetween 400-800 nm. In the preferred embodiment, the laser energysources 11, 12 are semiconductor laser diodes, one of which produceslight in the red range of the visible spectrum, having a wavelength ofabout 635 nm, while the other produces light in the violet range at awavelength of about 405 nm. Other suitable wavelengths include 440 nm,510 nm, and 530 nm, and the wavelengths may be used in differentcombinations. The preferred laser energy sources 11, 12 emit less thanone watt of power each. Diodes of various other wattages may also beemployed to achieve the desired laser energy for the given regimen.

In the preferred embodiment, the laser light is a continuous beam.Alternatively, the laser light may be pulsed. Pulse duration controllers21, 22 are connected to the laser energy sources 11, 12 respectively, toform a control circuit that controls the duration of each pulse of laserlight emitted, referred to herein as the pulse width. Pulse widths from0 to 100,000 Hz may be employed to achieve the desired effect on thefungus without adversely affecting the patient's tissue. The treatmentgoal is to deliver laser energy to the infected area utilizing a pulsewidth short enough to therapeutically effective against fungi whileavoiding damage to adjacent tissue or laser-induced sensation in thepatient's nerves.

Each laser beam 41, 42 exits the corresponding laser energy source 11,12 and is shone through optical arrangements 31, 32, respectively, thatproduce beam spots 1, 2 respectively of certain shapes. The beam spot isthe cross-sectional shape and size of the emitted beam as it impingesthe target area. For example, a laser beam of circular cross-sectioncreates a circular beam spot as the laser light impinges the treatmentarea. If the laser beam is in the visible range, a circular beam spotcan be seen on the treatment area of substantially the same diameter asthe laser beam emitted from the laser energy source, provided theoptical arrangement does not manipulate the laser beam. The laser beamcan be manipulated, such as by collimation, refraction, masking, oranother method of reshaping a laser beam, in order to produce beam spotsof different sizes and shapes. In the preferred embodiment, the laserbeams 41, 42 are shaped to produce linear beam spots on the patient.FIG. 2 illustrates an example optical arrangement 31 that includes acollimating lens 34 and a line generating prism 36. The collimating lens34 and the line generating prism 36 are disposed in serial relation tothe laser energy source 11. The collimating lens 34 and the linegenerating prism 36 receive and transform the generated beam of laserlight into the line of laser light L. As an alternative, a suitableelectrical or mechanical arrangement could be substituted for theoptical arrangement 31.

Referring to FIGS. 3 and 4, the preferred optical arrangement 31 is ascanning head used to create a beam spot on the treatment area. Tocreate the beam spot, the laser beam 41 emitted from the laser source 11is directed to the scanning head, which comprises a hollow spindle 20through which the laser beam 41 is conveyed. A rotatable carriage 18holds an optical element upon which the laser beam 41 is incident.Preferably, the laser beam 41, spindle 20 and carriage 18 aresubstantially co-axial. Preferably, a linear first beam spot L with itcenterpoint coaxial with the spindle 20 is generated by directing thelaser beam 41 to an optical element. A rod lens 35 is preferred as theoptical element, but a prism 36, as shown in FIG. 4 a, or other opticalelement or combination thereof may suffice. In other embodiments, thefirst beam spot may be another circular or non-circular shape, such as afilled or outlined polygon, a multi-pointed star, or a series ofparallel or crossing lines. As the carriage 18 rotates, the linear beamspot L rotates too, becoming, in essence, a rotating diameter of anapparent circular second beam spot. In the preferred embodiment, whenthe carriage 18 is rotated through at least 180°, the linear first beamspot L sweeps through a complete circle. Preferably, the carriage 18 isrotated slowly so that the beam spots 1, 2 impinge the same treatmentarea in an alternating pattern. Alternatively, with electronic orcomputerized control, the carriage 18 may automatically rotate veryquickly, causing the laser beam 41 to appear to create a substantiallycircular second beam spot on the patient's skin. The shape, however, isactually the result of the scanning light diameter sweeping fromlocation to location at a speed that makes the motion nearlyimperceptible to the human eye. The longer the line, the larger the beamspot.

The carriage 18 is rotated with a drive assembly. The drive assembly ispreferably a main drive gear 26 which is mated with a minor drive gear27. The minor drive gear 27 is driven by a main drive motor 25. Thecarriage 18 rotates around the axis as the main drive gear 26 is turned.Thus, the laser beam 41 from laser energy source 11 passes through thehollow spindle 20 and strikes an optical element which deflects thelaser beam into a linear beam spot L that, in combination with therotation, appears as a circular beam spot. Preferably, the laser beam 41remains coaxial with the hollow spindle 20 through the optical element,so that the center of the beam spot created by the optical element is onthe axis of the hollow spindle 20. The drive assembly may also becontrolled by micromanipulators according to signals received from acontrol pad 57, shown in FIGS. 6 and 7, which is further comprised ofvarious discrete circuits for controlling at least the scanning head andmay further control one or more of the laser energy sources, powersource, switches, and pulse duration controllers, as is known in theart. In a further form, the control pad 57 includes a microprocessorprogrammed to operate in various modes.

Referring to FIG. 5, the laser light may be directed to the desired areaon a patient using a hand-held wand 39. The wand 39 may be a housingcomprising an elongated hollow tube defining an interior cavity. Thelaser energy source 11 and optical arrangement 31 may be mounted in thewand's 39 interior cavity, although the laser energy source could beremotely located and the laser light conducted by fiber optics to thewand 39. The wand 39 may take on any shape that enables the laser lightto be directed as needed such as tubular, T-shaped, substantiallyspherical, or rectangular. The wand 39 may contain the power supply (forexample a battery) or the power supply may be remote with power suppliedby an electrical cable. As shown in FIG. 5, the laser sources 11, 12 maybe mounted inside the housing of a single wand 39. Alternatively,multiple wands 39 containing one or more laser sources may be provided.If scanning heads are used as the optical arrangement 31, a scanninghead may be contained wholly within each housing or attached separatelyto the end of each wand 39.

Preferably, the laser device operates in a stand-alone configuration.For example, the laser device may be supported by a support structuresuch as the wall or a portable stand that rests on the floor or table.This stand-alone arrangement enables a patient to be scanned by thelaser beam without using a handheld wand 39. Referring to FIG. 6, twohousings 49, 50 are attached to an arm 48 with connectors 44, 45,respectively. It will be understood that the laser device may have asingle housing or more than two housings, depending on the desirednumber of laser energy sources to be used. Similarly to the wand 39,each housing 49, 50 may contain one or more laser energy sources 11, 12,one or more optical arrangements 31, 32, and a power supply. Theconnectors 44, 45 may be rigid or, preferably, flexible, so that thehousings 49, 50 can be moved to any desired position. The arm 48 may bearticulated for additional control over the position of the lasers. Thearm 48 is attached to a base 46 having wheels 47 such that the devicecan be moved to any desired position and then stay substantiallystationary while treatment is occurring. This is particularly convenientfor patients lying on a table or sitting in wheelchair. The control pad57 is in electrical connection with the housings 49, 50 and may bemounted on the arm 48, in another location, or may operate as a remotecontrol using radio frequencies or other methods known in the art.

Referring to FIG. 7, a three-housing assembly 56 is attached to awall-mounted arm 51 which is affixed to the wall 52 in ways known in theart such that it can be moved to any desired position and then remainsubstantially stationary while therapy is occurring. The arm may bearticulated for additional control over the position of the lasers. Thecontrol pad 57 is in electrical connection with the housings 53, 54, 55and may be mounted on the wall. The control pad 57, however, can bemounted elsewhere or can operate as a remote control using radiofrequencies or other methods known in the art. The assembly 56 isattached to the arm 51 in ways known in the art such that it can bemoved to any desired position. Likewise, the housings 53, 54, 55 areattached to the assembly 56 so that each can be moved to a desiredposition.

FIGS. 8 a-10 illustrate the preferred laser device 100, which iscompact, portable, and free-standing. The laser device 100 is stationaryduring treatment, providing more uniform application of laser energythan a handheld device and occupying less space than known free-standingLLLT devices. Two housings 49, 50 are mounted in a shell 90, into whichthe patient places one or both feet or hands for treatment. It will beunderstood that, while the preferred laser device 100 includes twohousings 49, 50 for emitting laser light, a similarly-functioning devicemay be assembled using one, three, or more housings according to thedesired treatment parameters. The preferred laser device 100 preferablyoccupies less than two cubic feet of space. Most preferably, the shell90 has dimensions of about 15.5 inches in height, 10 inches in width,and 10.5 inches in depth, the depth being measured from the front to theback of the shell 90. The compact size of the shell 90 allows it to beplaced on a floor or countertop in a treatment room where little freespace is available. Additionally, the small device 100 may be easilytransported between rooms. The shell 90 comprises a back shell 91 andfront shell 92 that attach to each other and to a shell base 93 todefine an interior space. The back shell 91, front shell 92, and shellbase 93 may made of a molded polymer, or of metal such as aluminum orsteel. Preferably, the back shell 91 and front shell 92 aremedical-grade polymers, while the shell base 93 is aluminum so that thelaser device 100 is bottom-heavy and resistant to being knocked over.The back shell 91, front shell 92, and shell base 93 may be permanentlyor removably attached to each other, by adhesive or non-adhesive means.Preferably, metal or plastic screws are used to attach the back shell91, front shell 92, and shell base 93. A handle 86 may be attached tothe shell 90, preferably at the top of the back shell 91, for ease ofportability. Preferably, a plurality of height-adjustable, semi-rigidfeet 95 are attached to the bottom of the shell base 93. The feet 95protect the shell base 93 from scratches and other damage, and allow thelaser device 100 to be balanced on a surface that is not completelyplanar.

A door 73 covers an access port 71 disposed through the shell 90. Theaccess port 71 may be in the front, back, or side of the shell 90, butpreferably is disposed through the front shell 92 such that thepatient's foot or hand may pass through the access port 71 into theshell 90 and rest on the shell base 93, as illustrated, for treatment.Preferably, the access port 71 is no larger than necessary to receive asubstantial portion of one of the patient's feet, and is most preferablyabout 6.5 inches wide, about 5 inches tall, and about 8 inches deep,conforming closely to the size of the patient's hand or foot. In thismanner, the shell 90 provides a substantial shield from contaminatinglight during the procedure; that is, the laser energy may be applied tothe infected area in near darkness. The door 73 is closed when the laserdevice 100 is not in use, and open to allow the patient to place one orboth feet or hands into the device 100. Preferably, the door 73 fitsinto a recess 94 in the shell base 93, so that the outer surface of thedoor is substantially flush with the outer surface of the front shell 92when the door 73 is closed. The preferred door 73 then attaches to theshell base 93 with hinges 72 at the bottom of the door 73. The preferreddoor 73 also has one or more knobs 96 that serve a dual purpose ofproviding a surface to grab for opening the door 73, and contacting thesurface on which the laser device 100 is placed such that the door 73 ismaintained substantially parallel to the shell base 93 when open. SeeFIG. 10. The door 73 may then function as an extension of the topsurface of the shell base 93, on which the patient's feet or hands areplaced.

The housings 49, 50 are part of a scanning assembly 70 that issubstantially, preferably fully, enclosed in the shell 90. Within thescanning assembly 70, a programmable logic circuit (“PLC”) 76electrically receives one or more input parameters related to thetreatment to be performed. The input parameters may be received before,during, or after the treatment, and may be stored in the PLC 76 as apreset treatment. The PLC 76 uses the desired treatment parameters tocontrol the operations of the housings 49, 50. The operations of thehousings 49, 50 that may be controlled include: overall duration oflaser emission from each housing 49, 50; pulse width, variation of pulsewidth, and duration of each pulse width application; rotational speedand direction of carriage 18, if any; and area to scan. A voltageregulator 78 manages power conversion to direct current, if needed, andregulates the voltage applied to the PLC 76, touch screen 80 andhousings 49, 50. Typically, this voltage management includes reducingthe voltage from mains-standard 120V or 240V to 24V for the PLC 76 andtouch screen 80, and 5-8V to control the laser energy sources 11, 12 andany drive motors for rotating or oscillating optical arrangements 31,32. The voltage regulator 78 may be a component attached to the PCB 77as described below, or may be integrated into the PLC 76.

The housings 49, 50 are connected to a laser angle bridge 74 that setsthe angle of each housing 49, 50 with respect to vertical. Preferably,the housings 49, 50 are each offset about 15 degrees from vertical sothat the laser beams 41, 42 converge at a point about 5 inches below thehousings 49, 50. One or more non-conductive plates 75 isolate thehigh-voltage components, such as the PLC 76, from the patient. Theplates 75 are preferably plastic and most preferably DELRIN®. A mountingplate 79, typically made of reflective aluminum, separates the PLC 76and the electronic components of the interface described below from thehousings 49, 50, protecting the PLC 76 and the electronic componentsfrom the emitted laser light.

An interface, configured to display treatment options to a device 100operator and receive input from the operator, may be mounted in theshell 90, in electronic communication with the scanning assembly 70.Within the interface, electronic components mounted on a printed circuitboard (“PCB”) 77 electrically receive input parameters. The electroniccomponents may include transistors, resistors, capacitors, conductivetraces, and other components need to form a circuit configured toreceive input and transmit it to the PLC 76. An input device iselectrically connected to either the PLC 76 or the components of the PCB77, and receives the input from the operator. Preferably, the inputdevice is attached by universal serial bus (“USB”) connection to the PLC76. The input device may be a keyboard, mouse, touch screen, microphone,or other input device. Preferably, the input device is an integratedtouch screen 80 that displays options to the operator and receives theoperator's selections. Preferably, the touch screen 80 is attached withinterface mounts 83 installed in the front shell 92 above the door 73.Alternatively, the touch screen 80 or other combined or separate inputand output devices may be remote from the shell. The touch screen 80 mayreceive input, which preferably comprises treatment parameters, before,after, or during treatment. The laser device 100 may require a key to beinserted before the device may be used. The allows usage to be monitoredthrough key-checkout procedures, and also provides an emergency shutoffas required in the United States for certain alternating current-powereddevices. The key is inserted into a keyswitch 84 mounted in a keyswitchmount 85 near the touch screen 80. A power module 81 connects the deviceto a wall outlet or alternatively may be a battery that supplies powerto the device 100. The power module 81 is electrically connected to thevoltage regulator 78.

In any of the disclosed laser devices, but particularly in the preferredlaser device 100, parameters may be entered to program the wand 39 orany one of the housings 49, 50, 53, 54, 55 in a required manner toachieve any desired path upon the infected area of a patient.Furthermore, the device may be programmed to direct the laser outputinto some regions more than others so that one region may have greatertreatment than another region. The scan areas of multiple opticalarrangements 31, 32 may overlap, whether they emanate from the samehousing or separate housings. This may be particularly useful forstand-alone apparatuses using the present invention, such as thoseillustrated in FIGS. 6-10. The invention is not limited to anyparticular programmed operation mode, but by way of example thefollowing modes of operation are available:

-   -   1. The housing is programmed to scan the beam spot across a        series of fixed regions and dwell for a pre-set period at each        region. The regions may be input by a user to align with        particular positions on the patient that require irradiation.    -   2. The carriage 18 is rotated during treatment to sweep a region        of the treatment area. The rotational speed may be slow or fast,        and the speed may vary during the treatment.    -   3. The focal position of the beam shaping elements in the        optical arrangement 31, 32 is changed to generate smaller or        larger spot sizes on the patient.    -   4. The laser power is varied.

Preferably, including in the preferred laser device 100, the laserdevice employs two laser diodes each with an optical arrangement suchthat two substantially linear spot shapes are achieved. See FIG. 11.Further, the preferred laser device 100 has a first laser energy source11 that emits a laser beam having a 635 nm wavelength, and a secondlaser energy source 12 that emits a laser beam having a 405 nmwavelength. In alternative embodiments, the device may utilize as manylaser energy sources, wavelengths, and optical arrangements as necessaryto obtain the desired emissions and spot shapes. For example, more thantwo lasers may be used and optical arrangements aligned such that two ormore of the laser beams have substantially similar spot shapes and areco-incident where they impinge the patient's skin.

The disclosed laser device may, through proper application, reduce oreliminate fungi in the infected area by inciting certain processeswithin the fungal cells. The mitochondrial membrane of fungal cellscontains cytochrome c oxidase, an identified photoacceptor molecule.Laser light from LLLT reacts with this molecule, inducing the release ofhighly reactive superoxides that are toxic to the fungal cell. Moreover,laser therapy has been shown to promote superoxide dismutase (“SOD”), anenzyme responsible for the destruction of pathogens, bacteria, andrelated foreign organisms. Extracellular release of low levels ofmediators associated with SOD can increase the expression of chemokines,cytokines, and endothelial leukocyte adhesion molecules, amplifying thecascade that elicits the photodestructive response within the fungalcells.

The treatment method is performed on the patient's bare infected handsor feet. The present description uses feet and toenails to describe themethod, but it will be understood that the same treatment may be used oninfected hands and fingernails. The treatment is performed on each footindividually. The foot is placed flat on the floor or on a platform,with all infected nails being exposed. The laser device is positionedover the infected area. For treatments using a wand 39, the wand 39 maybe positioned so that it is touching the surface of the infected nail,or it may be held at a distance of up to about 6 inches from theinfected nail. For a standalone device, such as those illustrated inFIGS. 6 and 8 a, the housings 49, 50 are preferably positioned about 4-6inches above the infected area, most preferably about 5 inches above theinfected area. In other standalone devices, the housings may bepositioned about 10 inches or more from the infected surface. The deviceis activated and then laser light is moved slowly over the infectedareas, ensuring that each receives proper photonic exposure. The laserlight is preferably applied for between about 10 minutes and about 30minutes. If both feet are infected, the treatment is repeated for theother foot.

A therapeutic amount of laser energy is applied to halt fungal cellreproduction. The appropriate therapeutic amount may depend on one ormore of several factors, including: whether the infection is in the nailbed, nail plate, nail matrix, or other part of the nail; the depth andarea of the infection; the density of fungal cells in the infected area;the type of fungal cells; the thickness of the nail; the concurrent useof photoreceptive topical medications, and other factors. Preferably,therefore, the extent of the infection is assessed before beginninglaser energy application, so that treatment parameters may bedetermined. Alternatively, however, the patient may receive a dose oflaser energy that is known to be generally effective for most instancesof fungal infection, and the nail bed may be allowed to grow for aperiod of about 1-12 months to determine if the initial dose waseffective. The generally-effective dose may be repeated, with or withoutadjusted parameters, if new nail bed growth reveals that the infectionpersists. Laser energy applications of about 0.5 joules per squarecentimeter or more may be effective, but preferably between 0.5 and 15joules per square centimeter is applied to each foot during thetreatment. The generally effective dose has approximately the followingparameters: 12-minute application of laser energy, provided by a 405 nmbeam and a 635 nm beam, scanned over the area such that about 10-15joules per square centimeter total energy is applied. Typically, asingle application is sufficient, but more than one application mayimprove the speed at which the infected nail heals. Preferably, thedescribed application is repeated once, about five weeks after the firstapplication. The patient may apply a photoreceptive topical medicationthat is activated by the laser energy and helps inhibit fungal cellreproduction. The patient may apply a topical anti-fungal medication tothe infected area for 12 weeks to prevent re-infection. Successfultreatment will have halted fungal cell reproduction, so that thenewly-grown nail is infection free. The method results in improved nailgrowth rate, nail texture, and clarity, and reduced deformity.

While there has been illustrated and described what is at presentconsidered to be the preferred embodiment of the present invention, itwill be understood by those skilled in the art that various changes andmodifications may be made and equivalents may be substituted forelements thereof without departing from the true scope of the invention.Therefore, it is intended that this invention not be limited to theparticular embodiment disclosed, but that the invention will include allembodiments falling within the scope of the appended claims.

1. A laser device for applying low-level laser energy to an infectedarea of a patient's hands or feet, the laser device comprising: a. ashell having: i. an interior space of less than two cubic feet; and ii.an access port disposed through a portion of the shell such that thepatient may insert at least one hand or at least one foot through theaccess port into the interior space; and b. a scanning assembly attachedto the shell and disposed substantially within the interior space, thescanning assembly comprising: i. a first housing; and ii. a first laserenergy sources disposed within the first housing and configured to emita laser beam out of the first housing; the scanning assembly beingpositioned so the laser beam creates a first housing beam spotsubstantially impinging on the infected area when the patient's hand orfoot is in the interior space.
 2. The laser device of claim 1 whereinthe access port has dimensions of at least 6 inches wide and at least 8inches deep.
 3. The laser device of claim 1 wherein the scanningassembly further comprises one or more optical arrangements disposedwithin the first housing, the optical arrangements each comprising: a.one or more optical elements through which the laser beam is conveyed tomanipulate the laser beam such that the first housing beam spot isnon-circular.
 4. The laser device of claim 3 wherein each of the opticalarrangements further comprises: a. a rotatable carriage that holds theoptical element; and b. means for rotating the rotatable carriage suchthat the first housing beam spot also rotates.
 5. The laser device ofclaim 4 wherein the first housing beam spot is substantially linear. 6.The laser device of claim 1 wherein the scanning assembly furthercomprises: a. a second housing; b. a second laser energy source disposedwithin the second housing and configured to emit a laser beam out of thesecond housing to create a second housing beam spot that substantiallyimpinges on the infected area when a patient's hand or foot is placed inthe laser device.
 7. The laser device of claim 6 wherein the scanningassembly further comprises: a. a first optical arrangement disposedwithin the first housing, the first optical arrangement comprising: i.at least one first optical element through which the laser beamgenerated by the first laser energy source is conveyed to manipulate thelaser beam such that the first housing beam spot is non-circular; ii. afirst rotatable carriage that holds one or more of the first opticalelements; and iii. means for rotating the first rotatable carriage suchthat the first housing beam spot also rotates; and b. a second opticalarrangement disposed within the second housing, the second opticalarrangement comprising: i. at least one second optical element throughwhich the laser beam generated by the second laser energy source isconveyed to manipulate the laser beam such that the second housing beamspot is non-circular; ii. a second rotatable carriage that holds one ormore of the second optical elements; and iii. means for rotating thesecond rotatable carriage such that the second housing beam spot alsorotates.
 8. The laser device of claim 7 wherein at least one of thefirst housing beam spot and second housing beam spot is linear.
 9. Thelaser device of claim 7 wherein the first rotatable carriage and secondrotatable carriage are configured to rotate so that the first housingbeam spot and second housing beam spot impinge the same area atdifferent times during treatment.
 10. The laser device of claim 7wherein the scanning assembly further comprises a laser angle bridgeattached to the first housing and second housing and configured totranslate the first housing beam spot and second housing beam spotacross the infected area by changing the angles of the first housing andsecond housing with respect to the patient's foot or hand.
 11. The laserdevice of claim 1 wherein the scanning assembly further comprises alaser angle bridge attached to the first housing and configured totranslate the first housing beam spot across the infected area bychanging the angle of the first housing with respect to the patient'sfoot or hand.
 12. The laser device of claim 1 further comprising aninterface electrically connected to the scanning assembly, the interfaceconfigured to receive treatment parameters from an operator and transmitthe treatment parameters to the scanning assembly.
 13. The laser deviceof claim 12 wherein the interface is further configured to displaytreatment options to the operator.
 14. The laser device of claim 13wherein the interface comprises a touch screen.
 15. The laser device ofclaim 14 wherein the touch screen is mounted on the shell.
 16. The laserdevice of claim 1 further comprising a door attached to the shell andconfigured to close over the access port.
 17. The laser device of claim16 wherein the door is configured to open and to provide a surface onwhich the patient may place part of at least one hand or at least onefoot during application of the laser energy.
 18. A laser device forapplying low-level laser energy to an infected area of a patient's handsor feet, the laser device comprising: a. a substantially plastic shellcomprising: i. a front shell; ii. a back shell removably attached to thefront shell; iii. a shell base removably attached to the front shell andthe back shell to define an interior space, the shell base comprising anedge and a recess formed into the edge; and iv. an access port disposedthrough the front shell such that the patient may insert at least onehand or at least one foot through the access port into the interiorspace. b. a scanning assembly attached to the shell and disposed in theinterior space of the shell, the scanning assembly comprising: i. firstand second housings, each housing containing:
 1. one or more laserenergy sources, each having power output of less than 1 mW andconfigured to emit laser light having a wavelength of between 400 and800 nm; and
 2. one or more optical arrangements, each comprising: a. ahollow spindle substantially coaxial with a laser beam generated by oneof the laser energy sources, and through which the laser beam isconveyed; b. an optical element through which the laser beam is conveyedto produce a non-circular first beam spot whose centerpoint is along theaxis of the hollow spindle; and c. a rotatable carriage through whichthe laser beam is conveyed, the rotatable carriage holding the opticalelement; ii. a voltage regulator electrically attached to each of thelaser energy sources, the voltage regulator configured to start, stop,and regulate power supplied to the laser energy sources; iii. a laserangle bridge attached to each of the first and second housings, thelaser angle bridge configured to independently change the angle, withrespect to the shell base, of the first and second housings; iv. aprogrammable logic circuit electrically attached to the voltageregulator and the laser angle bridge, the programmable logic circuitconfigured to control the voltage regulator and the operations of thefirst and second housings according to specified treatment parameters;and v. a mounting plate disposed between the housings and theprogrammable logic circuit; the scanning assembly being positioned sothat the first beam spots of the first and second housings impingesubstantially on the infected area when the patient's hand or foot is inthe interior space and the laser energy sources are activated; c. aninterface electrically connected to the scanning assembly, the interfacecomprising: i. a touchscreen mounted on the front shell and configuredto display treatment options and receive treatment parameters from anoperator; and ii. a printed circuit board mounted on the mounting plateon the opposite side from the first and second housings, the printedcircuit board comprising electrical components in electricalcommunication with the touchscreen, the electrical components forming acircuit configured to receive the treatment parameters from thetouchscreen and deliver the treatment parameters to the programmablelogic controller; and d. a door having hinges, the door being attachedby the hinges to the shell base within the recess, such that the doorcovers the access port when closed and provides a surface on which thepatient may place at least one hand or at least one foot when opened.19. The laser device of claim 18 further comprising: a. a plurality offeet attached to the bottom of the shell base; and b. one or more knobsattached to the door such that when the door is fully opened, the knobscontact the surface on which the laser device is placed, maintaining theopen door substantially parallel to the shell base.
 20. The laser deviceof claim 19 further comprising a handle attached to the back shell.